Will IL case law align with the EPO approach to second medical indication patents?

A recent EPO Technical Board of Appeal decision highlights diverging approaches to the patentability of second medical indications, an issue now before the Israeli District Court.

In its decision of September 15, 2025, the TBA upheld a patent claiming the use of cabazitaxel in combination with prednisone or prednisolone to treat prostate cancer in patients with castration-resistant metastatic prostate cancer. The TBA held that the protocol for a Phase III clinical trial investigating the claimed treatment effect did not provide the skilled person with a reasonable expectation of success and did not render the invention obvious.

This decision brings to mind a contrasting decision of the retired Deputy Patents Commissioner of the ILPTO (IL Patent 236403) which departed from previous ILPTO case law. The Deputy Commissioner held that a patent claiming the use of ecopicam for the treatment of Tourette Syndrome at a daily oral dose of 50mg to 100mg lacks novelty and inventive step in view of a Phase I/II clinical trial protocol published on clinicaltrials.gov. This decision incorrectly regards the publication of the clinical trial protocol as an enabling disclosure for novelty purposes and further presumes that conducting a clinical trial creates a reasonable likelihood of success. The underlying assumptions which led to the decision are detached from the realities of pharmaceutical research, are inconsistent with EP and UK case law, which are a point of reference for the ILPTO, and the decision unnecessarily puts at risk the eligibility of second medical indications for patent protection.

The decision is currently under appeal at the District Court, and the outcome of the appeal will indicate whether Israeli patent law will move closer to the EPO jurisprudence assessing the patentability of second medical indications. It is perhaps an intriguing coincidence that the attorney who represented the applicant in this matter has since been appointed as Patents Commissioner.

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